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Title: Clinical trials on medicinal products in Malta following EU accession
Authors: Ellul, Ian C.
Calleja, Neville
Keywords: Clinical trials -- Law and legislation
Clinical trials -- Malta
Medical ethics committees -- Malta
European Union -- Malta -- Membership
Issue Date: 2006
Publisher: Malta Medical Journal
Citation: Malta Medical Journal. 2006, Vol.18(2), p. 41-43
Abstract: Following EU Accession, Malta has to adopt EU Directives as part of its own legislation. Three such directives concern the conduct of clinical trials in European countries ­ 2001/20/EC, 2003/94/EC and 2005/28/EC. These directives, and the respective guidelines explaining their implementation, have considerably changed the way clinical trials are conducted. While the participation of Malta in clinical trials is to be encouraged for various reasons, these have to be regulated according to the legislation set out by the European Union. In themselves, what these Directives strive to achieve are mainly the safety of the study subject and the protection of the investigators from serious consequences. This short article aims to give a brief overview of these changes to prospective investigators and hospital administrators.
Appears in Collections:MMJ, Volume 18, Issue 2
MMJ, Volume 18, Issue 2
Scholarly Works - FacM&SPH

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